CROSS-REFERNCE TO RELATED APPLICATIONS
TECHNICAL FIELD
[0002] The disclosure relates to an intracardiac ventricular pacemaker and associated method
for detecting atrial events from a motion sensor signal and controlling atrial-synchronized
ventricular pacing delivered by the pacemaker.
BACKGROUND
[0003] Implantable cardiac pacemakers are often placed in a subcutaneous pocket and coupled
to one or more transvenous medical electrical leads carrying pacing and sensing electrodes
positioned in the heart. A cardiac pacemaker implanted subcutaneously may be a single
chamber pacemaker coupled to one transvenous medical lead for positioning electrodes
in one heart chamber, atrial or ventricular, or a dual chamber pacemaker coupled to
two intracardiac leads for positioning electrodes in both an atrial and a ventricular
chamber. Multi-chamber pacemakers are also available that may be coupled to three
leads, for example, for positioning electrodes for pacing and sensing in one atrial
chamber and both the right and left ventricles.
[0004] Intracardiac pacemakers have recently been introduced that arc implantable within
a ventricular chamber of a patient's heart for delivering ventricular pacing pulses.
Such a pacemaker may sense R-wave signals attendant to intrinsic ventricular depolarizations
and deliver ventricular pacing pulses in the absence of sensed R-waves. While single
chamber ventricular sensing and pacing by an intracardiac ventricular pacemaker may
adequately address some patient conditions, other conditions may require atrial and
ventricular (dual chamber) sensing for providing atrial-synchronized ventricular pacing
in order to maintain a regular heart rhythm
SUMMARY
[0005] In general, the disclosure is directed to a ventricular pacemaker and techniques
for detecting atrial systolic events from a motion sensor signal for controlling atrial-synchronized
ventricular pacing by the ventricular pacemaker. A pacemaker operating according to
the techniques disclosed herein sets a detection control parameter for detecting an
atrial systolic event that occurs after a ventricular diastolic event and for detecting
an atrial systolic event that has become fused with the ventricular diastolic event.
The pacemaker sets an atrioventricular pacing interval in response to detecting atrial
systolic events for providing atrial-synchronized ventricular pacing.
[0006] In one example, the disclosure provides an intracardiac ventricular pacemaker, including
a pulse generator, a motion sensor and a control circuit. The pulse generator is configured
to generate and deliver pacing pulses to a ventricle of a patient's heart via electrodes
coupled to the pacemaker. The motion sensor is configured to produce a motion signal
comprising an atrial systolic event. and a ventricular diastolic event indicating
a passive ventricular filling phase. The control circuit is coupled to the motion
sensor and the pulse generator and is configured to set a detection threshold to a
first amplitude during an expected time interval of the ventricular diastolic event
and to a second amplitude lower than the first amplitude after the expected time interval
of the ventricular diastolic event. The control circuit detects the atrial systolic
event in response to the motion signal crossing the detection threshold, sets an atrioventricular
pacing interval in response to detecting the atrial systolic event, and controls the
pulse generator to deliver a pacing pulse to the ventricle in response to the atrioventricular
pacing interval expiring.
[0007] In another example, the disclosure provides a method performed by an intracardiac
pacemaker having a motion sensor. The method includes producing by the motion sensor
a motion signal comprising an atrial systolic event and a ventricular diastolic event
indicating a passive ventricular filling phase, setting a detection threshold to a
first amplitude during an expected time interval of the ventricular diastolic event
and to a second amplitude lower than the first amplitude after an expected time interval
of the ventricular diastolic event, detecting the atrial systolic event in response
to the motion signal crossing the detection threshold, setting an atrioventricular
pacing interval in response to detecting the atrial systolic event, and delivering
a pacing pulse to a ventricle of a patient's heart via electrodes coupled to the pacemaker
in response to the atrioventricular pacing interval expiring.
[0008] In yet another example, the disclosure provides a non-transitory computer-readable
medium storing a set of instructions which when executed by a control circuit of an
intracardiac ventricular pacemaker having a motion sensor, cause the pacemaker to
produce by the motion sensor a motion signal comprising an atrial systolic event and
a ventricular diastolic event indicating a passive ventricular filling phase, set
a detection threshold to a first amplitude during an expected time interval of the
ventricular diastolic event and to a second amplitude lower than the first amplitude
after an expected time interval of the ventricular diastolic event, detect the atrial
systolic event in response to the motion signal crossing the detection threshold,
set an atrioventricular pacing interval in response to detecting the atrial systolic
event, and deliver a pacing pulse upon expiration of the atrioventricular pacing interval
to a ventricle of a patient's heart via electrodes coupled to the pacemaker.
[0009] This summary is intended to provide an overview of the subject matter described in
this disclosure. It is not intended to provide an exclusive or exhaustive explanation
of the apparatus and methods described in detail within the accompanying drawings
and description below. Further details of one or more examples are set forth in the
accompanying drawings and the description below.
BRIEF DESCRIPTION OF DRAWINGS
[0010]
FIG. 1 is a conceptual diagram illustrating an intracardiac pacing system that may
be used to sense cardiac electrical signals and motion signals induced by cardiac
motion and flowing blood and provide pacing therapy to a patient's heart,
FIG. 2A is a conceptual diagram of the intracardiac ventricular pacemaker shown in
FIG. 1.
FIG. 2B is a conceptual diagram of another example of the intracardiac ventricular
pacemaker shown in FIG. 1.
FIG. 3 is a schematic diagram of an example configuration of the pacemaker of FIG.
2A.
FIG. 4 is an example of a motion sensor signal that may be acquired over a cardiac
cycle by a motion sensor included in the ventricular intracardiac pacemaker of FIG.
1.
FIG. 5 is a flow chart of one method performed by an intracardiac ventricular pacemaker
for detecting an atrial systolic event from a motion sensor signal and controlling
ventricular pacing.
FIG. 6 is an example of a motion sensor signal acquired over two different ventricular
cycles.
FIG. 7 is an averaged motion sensor signal.
FIG. 8 is a flow chart of a method performed by an intracardiac ventricular pacemaker
for detecting atrial events and controlling atrial-synchronized ventricular pacing
according to another example.
FIG. 9 is a flow chart of a method for detecting atrial systolic events from a motion
sensor signal for controlling atrial-synchronized ventricular pacing.
FIG. 10 is a timing diagram of a motion sensor signal that may be received by an intracardiac
ventricular pacemaker.
FIG. 11 is a flow chart of a method for controlling atrial synchronized ventricular
pacing by an intracardiac pacemaker according to another example.
FIG. 12 is a flow chart of another example of a method for controlling atrial-synchronized
ventricular pacing by an intracardiac pacemaker.
FIG. 13 is a flow chart of a method for controlling ventricular pacing by an intracardiac
pacemaker according to yet another example.
DETAILED DESCRIPTION
[0011] FIG. 1 is a conceptual diagram illustrating an intracardiac pacing system 10 that
may be used to sense cardiac electrical signals and motion signals induced by cardiac
motion and flowing blood and provide pacing therapy to a patient's heart 8. IMD system
10 includes a right ventricular (RV) intracardiac pacemaker 14 and may optionally
include a right atrial (RA) intracardiac pacemaker 12 in some examples. Pacemakers
12 and 14 arc transcatheter intracardiac pacemakers which may be adapted for implantation
wholly within a heart chamber, e.g., wholly within the RV, wholly within the left
ventricle (LV), wholly within the RA or wholly within the left atrium (LA) of heart
8.
[0012] In the example of FIG. 1, pacemaker 12 is positioned along an endocardial wall of
the RA, e.g., along the RA lateral wall or RA septum. Pacemaker 14 is positioned along
an endocardial wall of the RV, e.g., near the RV apex though other locations are possible.
The techniques disclosed herein are not limited to the pacemaker locations shown in
the example of FIG. 1 and other positions and relative locations in the heart 8 and
from each other are possible. For example, a ventricular intracardiac pacemaker 14
may be positioned in the LV for and configured to detect cardiac motion signals and
deliver atrial-synchronized ventricular pacing to the LV using the techniques disclosed
herein.
[0013] Pacemakers 12 and 14 are reduced in size compared to subcutaneously implanted pacemakers
and may be generally cylindrical in shape to enable transvenous implantation via a
delivery catheter. In other examples, pacemakers 12 and 14 may be positioned at any
other location inside heart 8. For example, pacemaker 12 may be positioned outside
or within the right atrium or left atrium to provide respective right atrial or left
atrial pacing. Pacemaker 14 may be positioned within the right ventricle or left ventricle
to provide respective right ventricular or left ventricular pacing and for sensing
motion signals by a motion sensor within the ventricular chamber.
[0014] Pacemakers 12 and 14 are each capable of producing electrical stimulation pulses,
e.g., pacing pulses, delivered to heart 8 via one or more electrodes on the outer
housing of the pacemaker. RA pacemaker 12 is configured to sense a cardiac electrical
signal from within the RA that may be used to produce an RA intracardiac electrogram
(EGM) signal. RV pacemaker 14 is configured to deliver RV pacing pulses and sense
an RV cardiac electrical signal using housing based electrodes for producing an RV
EGM signal. The cardiac electrical signals may be sensed by the respective pacemaker
12 or 14 using the housing based electrodes that are also used to deliver pacing pulses
to the respective RA or RV.
[0015] In some examples, a patient may only require RV pacemaker 14 for delivering ventricular
pacing. In other examples, depending on individual patient need, RA pacemaker 12 may
be required for delivering atrial pacing. The RV pacemaker 14 is configured to control
the delivery of ventricular pacing pulses to the RV in a manner that promotes synchrony
between the RA activation and the RV activation, e.g., by maintaining a target atrioventricular
(AV) interval between atrial events and ventricular pacing pulses. That is, the RV
pacemaker 14 controls RV pacing pulse delivery to maintain a desired AV interval between
atrial activations (intrinsic or pacing-evoked) corresponding to atrial systole and
ventricular pacing pulses delivered to cause ventricular depolarization.
[0016] According to the techniques described herein, atrial activations are detected by
RV pacemaker 14 from a motion sensor signal that includes motion signals caused by
ventricular and atrial events. For example, acceleration of blood flowing into the
RV through the tricuspid valve 16 between the RA and RV caused by atrial activation,
sometimes referred to as the "atrial kick," is detected by RV pacemaker 14 from the
signal produced by a motion sensor, for example an accelerometer, included in RV pacemaker
14. Other motion signals detected by RV pacemaker 14, such as motion caused by ventricular
contraction, motion caused by ventricular relaxation, and motion caused by passive
filling of the ventricle are described below in conjunction with FIG. 4.
[0017] Atrial P-waves that are attendant to atrial depolarization are relatively low amplitude
signals in the near-field RV cardiac electrical signal received by pacemaker 14 (e.g.,
compared to the near-field R-wave) and therefore can be difficult to reliably detect
from the cardiac electrical signal acquired by RV pacemaker 14. As such, atrial-synchronized
ventricular pacing by RV pacemaker 14 may not be reliable when based solely on a cardiac
electrical signal received by RV pacemaker 14. According to the techniques disclosed
herein, the RV pacemaker 14 includes a motion sensor, such as an accelerometer, and
is configured to detect an atrial event corresponding to atrial mechanical activation
or atrial systole using a signal from the motion sensor. Ventricular pacing pulses
arc synchronized to the atrial event that is detected from the accelerometer signal
by setting a programmable atrioventricular (AV) pacing interval that controls the
timing of the ventricular pacing pulse relative to the detected atrial systolic event.
As described below, detection of the atrial systolic event used to synchronize ventricular
pacing pulses to atrial systole may include detection of other cardiac event motion
signals in order to positively identify the atrial systolic event.
[0018] A target AV interval may be a programmed value selected by a clinician and is the
time interval from the detection of the atrial event until delivery of the ventricular
pacing pulse. In some instances, the target AV interval may be started from the time
the atrial systolic event is detected based on a motion sensor signal or starting
from an identified fiducial point of the atrial event signal. The target AV interval
may be identified as being hemodynamically optimal for a given patient based on clinical
testing or assessments of the patient or based on clinical data from a population
of patients. The target AV interval may be determined to be optimal based on relative
timing of electrical and mechanical events as identified from the cardiac electrical
signal received by RV pacemaker 14 and the motion sensor signal received by RV pacemaker
14.
[0019] Pacemakers 12 and 14 may each be capable of bidirectional wireless communication
with an external device 20 for programming the AV pacing interval and other pacing
control parameters as well as mechanical event sensing parameters utilized for detecting
ventricular mechanical events and the atrial systolic event from the motion sensor
signal. Aspects of external device 20 may generally correspond to the external programming/monitoring
unit disclosed in
U.S. Pat. No. 5,507,782 (Kieval, et al.), hereby incorporated herein by reference in its entirety. External device 20 is
often referred to as a "programmer" because it is typically used by a physician, technician,
nurse, clinician or other qualified user for programming operating parameters in pacemakers
12 and 14. External device 20 may be located in a clinic, hospital or other medical
facility. External device 20 may alternatively be embodied as a home monitor or a
handheld device that may be used in a medical facility, in the patient's home, or
another location. Operating parameters, including sensing and therapy delivery control
parameters, may be programmed into pacemakers 12 and 14 using external device 20.
[0020] External device 20 is configured for bidirectional communication with implantable
telemetry circuitry included in RV pacemaker 14 and RA pacemaker 12 (when present).
External device 20 establishes a wireless radio frequency (RF) communication link
22 with RA pacemaker 12 and wireless RF communication link 24 with RV pacemaker 14
using a communication protocol that appropriately addresses the targeted pacemaker
12 or 14. Communication links 22 and 24 may be established using an RF link such as
BLUETOOTH
®, Wi-Fi, Medical Implant Communication Service (MICS) or other communication bandwidth.
In some examples, external device 20 may include a programming head that is placed
proximate pacemaker 12 or 14 to establish and maintain a communication link, and in
other examples external device 20 and pacemakers 12 and 14 may be configured to communicate
using a distance telemetry algorithm and circuitry that does not require the use of
a programming head and does not require user intervention to maintain a communication
link. An example RF telemetry communication system that may be implemented in system
10 is generally disclosed in
U.S. Pat. No. 5,683,432 (Goedeke, et al.), hereby incorporated herein by reference in its entirety.
[0021] External device 20 may display data and information relating to pacemaker functions
to a user for reviewing pacemaker operation and programmed parameters as well as EGM
signals transmitted from pacemaker 14 or pacemaker 12, motion sensor signals acquired
by pacemaker 14, or other physiological data that is acquired by and retrieved from
pacemakers 12 and/or 14 during an interrogation session.
[0022] It is contemplated that external device 20 may be in wired or wireless connection
to a communications network via a telemetry circuit that includes a transceiver and
antenna or via a hardwired communication line for transferring data to a remote database
or computer to allow remote management of the patient. Remote patient management systems
including a remote patient database may be configured to utilize the presently disclosed
techniques to enable a clinician to review EGM, motion sensor, and marker channel
data and authorize programming of sensing and therapy control parameters in RV pacemaker
14, e.g., after viewing a visual representation of EGM. motion sensor signal and marker
channel data
[0023] Pacemaker 12 and pacemakcr 14 may or may not be configured to communicate directly
with each other. When pacemakers 12 and 14 are configured to communicate with each
other, communication may be minimized in order to conserve battery life of the intracardiac
pacemakers 12 and 14. As such, communication may not occur on a beat-by-beat basis
between the RA pacemaker 12 and RV pacemaker 14 for communicating when the other pacemaker
is sensing cardiac events or when it is delivering pacing pulses. As disclosed herein,
RV pacemaker 14, however, is configured to detect atrial events as often as beat-by-beat
from a motion sensor signal, without requiring communication signals from RA pacemaker
12 to provide atrial event detection for controlling atrial-synchronized ventricular
pacing.
[0024] FIG. 2A is a conceptual diagram of the intracardiac RV pacemaker 14 shown in FIG.
1. RV pacemaker 14 includes electrodes 162 and 164 spaced apart along the housing
150 of pacemaker 14 for sensing cardiac electrical signals and delivering pacing pulses.
Electrode 164 is shown as a tip electrode extending from a distal end 102 of pacemaker
14, and electrode 162 is shown as a ring electrode along a mid-portion of housing
150, for example adjacent proximal end 104. Distal end 102 is referred to as "distal"
in that it is expected to be the leading end as pacemaker 14 is advanced through a
delivery tool, such as a catheter, and placed against a targeted pacing site.
[0025] Electrodes 162 and 164 form an anode and cathode pair for bipolar cardiac pacing
and sensing. In alternative embodiments, pacemaker 14 may include two or more ring
electrodes, two tip electrodes, and/or other types of electrodes exposed along pacemaker
housing 150 for delivering electrical stimulation to heart 8 and sensing cardiac electrical
signals. Electrodes 162 and 164 may be, without limitation, titanium, platinum, iridium
or alloys thereof and may include a low polarizing coating, such as titanium nitride,
iridium oxide, ruthenium oxide, platinum black among others. Electrodes 162 and 164
may be positioned at locations along pacemaker 14 other than the locations shown.
[0026] Housing 150 is formed from a biocompatible material, such as a stainless steel or
titanium alloy. In some examples, the housing 150 may include an insulating coating.
Examples of insulating coatings include parylene, urethane, PEEK, or polyimide among
others. The entirety of the housing 150 may be insulated, but only electrodes 162
and 164 uninsulated. Electrode 164 may serve as a cathode electrode and be coupled
to internal circuitry, e.g., a pacing pulse generator and cardiac electrical signal
sensing circuitry, enclosed by housing 150 via an electrical feedthrough crossing
housing 150. Electrode 162 may be formed as a conductive portion of housing 150 as
a ring electrode that is electrically isolated from the other portions of the housing
150 as generally shown in FIG. 2A. In other examples, the entire periphery of the
housing 150 may function as an electrode that is electrically isolated from tip electrode
164, instead of providing a localized ring electrode such as anode electrode 162.
Electrode 162 formed along an electrically conductive portion of housing 150 serves
as a return anode during pacing and sensing.
[0027] The housing 150 includes a control electronics subassembly 152, which houses the
electronics for sensing cardiac signals, producing pacing pulses and controlling therapy
delivery and other functions of pacemaker 14 as described below in conjunction with
FIG. 3. A motion sensor may be implemented as an accelerometer enclosed within housing
150 in some examples. The accelerometer provides a signal to a processor included
in control electronics subassembly 152 for signal processing and analysis for detecting
ventricular mechanical events and atrial systolic events for timing ventricular pacing
pulses as described below.
[0029] Pacemaker 14 may include a set of fixation tines 166 to secure pacemaker 14 to patient
tissue, e.g., by actively engaging with the ventricular endocardium and/or interacting
with the ventricular trabeculae. Fixation tines 166 are configured to anchor pacemaker
14 to position electrode 164 in operative proximity to a targeted tissue for delivering
therapeutic electrical stimulation pulses. Numerous types of active and/or passive
fixation members may be employed for anchoring or stabilizing pacemaker 14 in an implant
position. Pacemaker 14 may include a set of fixation tines as disclosed in commonly-assigned,
pre-grant publication
U.S. 2012/0172892 (Grubac, et al.), hereby incorporated herein by reference in its entirety.
[0030] Pacemaker 14 may optionally include a delivery tool interlace 158. Delivery tool
interface 158 may be located at the proximal end 104 of pacemaker 14 and is configured
to connect to a delivery device, such as a catheter, used to position pacemaker 14
at an implant location during an implantation procedure, for example within a heart
chamber.
[0031] FIG. 2B is a conceptual diagram of another example of RV pacemaker 14. In FIG. 2B,
RV pacemaker 14 includes a proximal sensing extension 165 extending away from housing
150 and carrying a pair of sensing electrodes 167 and 168. The proximal sensing extension
165 may be coupled to the housing 150 for positioning a return sensing electrode 168
or 167 which may be paired with distal electrode 164 at an increased inter-electrode
distance compared to the inter-electrode spacing of housing-based electrodes 162 and
164. The increased inter-electrode distance may facilitate sensing of far-field atrial
signals such as P-waves attendant to atrial depolarization.
[0032] Alternatively, electrodes 167 and 168 may form a sensing electrode pair for sensing
atrial P-waves. When distal end 102 is fixed along the RV apex, sensing extension
165 may extend toward the RA thereby positioning electrodes 167 and 168 nearer the
atrial tissue for sensing far-field atrial P-waves. One electrode 167 may be coupled
to sensing circuitry enclosed in housing 150 via an electrical feedthrough crossing
housing 150, and one electrode 168 may be coupled to housing 150 to serve as a ground
electrode.
[0033] FIG. 3 is a schematic diagram of an example configuration of pacemaker 14 shown in
FIG. 1. Pacemaker 14 includes a pulse generator 202, a sensing circuit 204, a control
circuit 206, memory 210, telemetry circuit 208, motion sensor 212 and a power source
214. Motion sensor 212 is implemented as an accelerometer in the examples described
herein and may also be referred to herein as "accelerometer 212." Motion sensor 212
is not limited to being an accelerometer, however, and other motion sensors may be
utilized successfully in pacemaker 14 for detecting cardiac motion signals according
to the techniques described herein. Examples of motion sensors that may be implemented
in pacemaker 14 include piezoelectric sensors and micro electro-mechanical systems
(MEMS) devices.
[0034] Motion sensor 212 may be a multi-axis sensor, e.g., a two-dimensional or three-dimensional
sensor, with each axis providing a signal that may be analyzed individually or in
combination for detecting cardiac mechanical events. Motion sensor 212 produces an
electrical signal correlated to motion or vibration of sensor 212 (and pacemaker 14),
e.g., when subjected to flowing blood and cardiac motion. Motion sensor 212 may be
a onedimensional, single axis accelerometer, two-dimensional or three-dimensional
multi-axis accelerometer. One example of an accelerometer for use in implantable medical
devices is generally disclosed in
U.S. Pat. No. 5,885,471 (Ruben, et al.), incorporated herein by reference in its entirety. An implantable medical device
arrangement including a piezoelectric accelerometer for detecting patient motion is
disclosed, for example, in
U.S. Pat. No. 4,485,813 (Anderson, et al.) and
U.S. Pat. No. 5,052,388 (Sivula, et al.), both of which patents are hereby incorporated by reference herein in their entirety.
Examples of three-dimensional accelerometers that may be implemented in pacemaker
14 and used for detecting cardiac mechanical events using the presently disclosed
techniques are generally described in
U.S. Pat. No. 5,593,431 (Sheldon) and
U.S. Pat. No. 6,044,297 (Sheldon), both of which are incorporated herein by reference in their entirety. Other accelerometer
designs may be used for producing an electrical signal that is correlated to motion
imparted on pacemaker 14 due to ventricular and atrial events.
[0035] The various circuits represented in FIG. 3 may be combined on one or more integrated
circuit boards which include a specific integrated circuit (ASIC), an electronic circuit,
a processor (shared, dedicated, or group) and memory that execute one or more software
or firmware programs, a combinational logic circuit, state machine or other suitable
components that provide the described functionality.
[0036] Sensing circuit 204 is configured to receive a cardiac electrical signal via electrodes
162 and 164 by a pre-filter and amplifier circuit 220. Pre-filter and amplifier circuit
may include a high pass filter to remove DC offset, e.g., a 2.5 to 5 Hz high pass
filter, or a wideband filter having a passband of 2.5 Hz to 100 Hz to remove DC offset
and high frequency noise. Pre-filter and amplifier circuit 220 may further include
an amplifier to amplify the "raw" cardiac electrical signal passed to analog-to-digital
converter (ADC) 226. ADC 226 may pass a multi-bit, digital electrogram (EGM) signal
to control circuit 206 for use by atrial event detector circuit 240 in identifying
ventricular electrical events (e.g., R-waves or T-waves) and/or atrial electrical
events, e.g., P-waves. Identification of cardiac electrical events may be used in
algorithms for detecting atrial systolic events from the motion sensor signal. The
digital signal from ADC 226 may be passed to rectifier and amplifier circuit 222,
which may include a rectifier, bandpass filter, and amplifier for passing a cardiac
signal to R-wave detector 224.
[0037] R-wave detector 224 may include a sense amplifier or other detection circuitry that
compares the incoming rectified, cardiac electrical signal to an R-wave detection
threshold, which may be an auto-adjusting threshold. When the incoming signal crosses
the R-wave detection threshold, the R-wave detector 224 produces an R-wave sensed
event signal (R-sense) that is passed to control circuit 206. In other examples, R-wave
detector 224 may receive the digital output of ADC 226 for detecting R-waves by a
comparator, morphological signal analysis of the digital EGM signal or other R-wave
detection techniques. R-wave sensed event signals passed from R-wave detector 224
to control circuit 206 may be used for scheduling ventricular pacing pulses by pace
timing circuit 242 and for use in identifying the timing of ventricular electrical
events in algorithms performed by atrial event detector circuit 240 for detecting
atrial systolic events from a signal received from motion sensor 212.
[0038] Control circuit 206 includes an atrial event detector circuit 240, pace timing circuit
242, and processor 244. Atrial event detector circuit 240 is configured to detect
atrial mechanical events from a signal received from motion sensor 212. As described
below, one or more ventricular mechanical events may be detected from the motion sensor
signal in a given cardiac cycle to facilitate positive detection of the atrial systolic
event from the motion sensor signal during the ventricular cycle.
[0039] Control circuit 206 may receive R-wave sensed event signals and/or digital cardiac
electrical signals from sensing circuit 204 for use in detecting and confirming cardiac
events and controlling ventricular pacing. For example, R-wave sensed event signals
may be passed to pace timing circuit 242 for inhibiting scheduled ventricular pacing
pulses or scheduling ventricular pacing pulses when pacemaker 14 is operating in a
non-atrial tracking ventricular pacing mode. R-wave sensed event signals may also
be passed to atrial event detector circuit 240 for use in setting ventricular event
detection windows and/or atrial event refractory periods, for example as shown and
described in conjunction with FIG. 6.
[0040] Atrial event detector circuit 240 receives a motion signal from motion sensor 212
and starts an atrial refractory period in response to a ventricular electrical event,
e.g., an R-wave sensed event signal from sensing circuit 204 or delivery of a pacing
pulse by pulse generator 202. Atrial event detector circuit 240 determines if the
motion sensor signal satisfies atrial mechanical event detection criteria outside
of the refractory period. The motion sensor signal during the refractory period may
be monitored by atrial event detector circuit 240 for the purposes of detecting ventricular
mechanical events, which may be used for confirming or validating atrial systolic
event detection and/or setting atrial systolic event detection control parameters
as further described below, e.g., in conjunction with FIG 10. As such, ventricular
mechanical event detection windows may be set during the atrial refractory period
and may be set according to predetermined time intervals following identification
of a ventricular electrical event. Atrial event detector circuit 240 may be configured
to detect one or more ventricular mechanical events during respective ventricular
event detection windows during the atrial refractory period. The timing and detection
of the ventricular mechanical events may be used to update the atrial refractory period
and/or an atrial systolic detection threshold amplitude and may be used to confirm
detection of the atrial systolic event occurring subsequent to expected ventricular
mechanical events.
[0041] Atrial event detector circuit 240 passes an atrial event detection signal to processor
244 and/or pace timing circuit 242. Pace timing circuit 242 (or processor 244) may
additionally receive R-wave sensed event signals from R-wave detector 224 for use
in controlling the timing of pacing pulses delivered by pulse generator 202. Processor
244 may include one or more clocks for generating clock signals that are used by pace
timing circuit 242 to time out an AV pacing interval that is started upon receipt
of an atrial event detection signal from atrial event detector circuit 240. Pace timing
circuit 242 may include one or more pacing escape interval timers or counters that
are used to time out the AV pacing interval, which may be a programmable interval
stored in memory 210 and retrieved by processor 244 for use in setting the AV pacing
interval used by pace timing circuit 242.
[0042] Pace timing circuit 242 may additionally include a lower pacing rate interval timer
for controlling a minimum ventricular pacing rate. For example, if an atrial systolic
event is not detected from the motion sensor signal triggering a ventricular pacing
pulse at the programmed AV pacing interval, a ventricular pacing pulse may be delivered
by pulse generator 202 upon expiration of the lower pacing rate interval to prevent
ventricular asystole and maintain a minimum ventricular rate.
[0043] Processor 244 may retrieve other programmable pacing control parameters, such as
pacing pulse amplitude and pacing pulse width that are passed to pulse generator 202
for controlling pacing pulse delivery. In addition to providing control signals to
pace timing circuit 242 and pulse generator 202 for controlling pacing pulse delivery,
processor 244 may provide sensing control signals to sensing circuit 204, e.g., R-wave
sensing threshold, sensitivity, various blanking and refractory intervals applied
to the cardiac electrical signal, and atrial event detection control signals to atrial
event detector circuit 240 for use in detecting and confirming atrial systolic events,
e.g., ventricular event detection windows, atrial refractory period, detection threshold
amplitudes applied to the motion sensor signal, and any other atrial event detection
criteria applied by circuitry included in atrial event detector circuit 240.
[0044] The functions attributed to pacemaker 14 herein may be embodied as one or more processors,
controllers, hardware, firmware, software, or any combination thereof. Depiction of
different features as specific circuitry is intended to highlight different functional
aspects and does not necessarily imply that such functions must be realized by separate
hardware, firmware or software components or by any particular circuit architecture.
Rather, functionality associated with one or more circuits described herein may be
performed by separate hardware, firmware or software components, or integrated within
common hardware, firmware or software components. For example, atrial systolic event
detection from the motion sensor signal and ventricular pacing control operations
performed by pacemaker 14 may be implemented in control circuit 206 executing instructions
stored in memory 210 and relying on input from sensing circuit 204 and motion sensor
212.
[0045] The operation of circuitry included in pacemaker 14 as disclosed herein should not
be construed as reflective of a specific form of hardware, firmware and software necessary
to practice the techniques described. It is believed that the particular form of software,
hardware and/or firmware will be determined primarily by the particular system architecture
employed in the pacemaker 14 and by the particular sensing and therapy delivery circuitry
employed by the pacemaker 14. Providing software, hardware, and/or firmware to accomplish
the described functionality in the context of any modem pacemaker, given the disclosure
herein, is within the abilities of one of skill in the art.
[0046] Pulse generator 202 generates electrical pacing pulses that are delivered to the
RV of the patient's heart via cathode electrode 164 and return anode electrode 162.
Pulse generator 202 may include charging circuit 230, switching circuit 232 and an
output circuit 234 Charging circuit 230 may include a holding capacitor that may be
charged to a pacing pulse amplitude by a multiple of the battery voltage signal of
power source 214 under the control of a voltage regulator. The pacing pulse amplitude
may be set based on a control signal from control circuit 206. Switching circuit 232
may control when the holding capacitor of charging circuit 230 is coupled to the output
circuit 234 for delivering the pacing pulse. For example, switching circuit 232 may
include a switch that is activated by a timing signal received from pace timing circuit
242 upon expiration of an AV pacing interval (or lower rate pacing interval) and kept
closed for a programmed pacing pulse duration to enable discharging of the holding
capacitor of charging circuit 230. The holding capacitor, previously charged to the
pacing pulse voltage amplitude, is discharged across electrodes 162 and 164 through
the output capacitor of output circuit 234 for the programmed pacing pulse duration.
Examples of pacing circuitry generally disclosed in
U.S. Pat No. 5,507,782 (Kieval, et al.) and in commonly assigned
U.S. Pat. No. 8,532,785 (Crutchfield, et al.), both of which patents are incorporated herein by reference in their entirety, may
be implemented in pacemaker 14 for charging a pacing capacitor to a predetermined
pacing pulse amplitude under the control of control circuit 206 and delivering a pacing
pulse.
[0047] Memory 210 may include computer-readable instructions that, when executed by control
circuit 206, cause control circuit 206 to perform various functions attributed throughout
this disclosure to pacemaker 14. The computer-readable instructions may be encoded
within memory 210. Memory 210 may include any non-transitory, computer-readable storage
media including any volatile, non-volatile, magnetic, optical, or electrical media,
such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM),
electrically-erasable programmable ROM (EEPROM), flash memory, or other digital media
with the sole exception being a transitory propagating signal. Memory 210 may store
timing intervals and other data used by control circuit 206 to control the delivery
of pacing pulses by pulse generator 202, e.g., by detecting an atrial systolic event
by atrial event detector circuit 240 from the motion sensor signal and setting a pacing
escape interval timer included in pace timing circuit 242, according to the techniques
disclosed herein.
[0048] Power source 214 provides power to each of the other circuits and components of pacemaker
14 as required. Control circuit 206 may execute power control operations to control
when various circuits or components are powered to perform various pacemaker functions.
Power source 214 may include one or more energy storage devices, such as one or more
rechargeable or non-rechargeable batteries. The connections between power source 214
and other pacemaker circuits and components are not shown in FIG. 3 for the sake of
clarity.
[0049] Telemetry circuit 208 includes a transceiver 209 and antenna 211 for transferring
and receiving data via a radio frequency (RF) communication link. Telemetry circuit
208 may be capable of bi-directional communication with external device 20 (Fig. 1)
as described above. Motion sensor signals and cardiac electrical signals, and/or data
derived therefrom may be transmitted by telemetry circuit 208 to external device 20.
Programmable control parameters and algorithms for performing atrial event detection
and ventricular pacing control may be received by telemetry circuit 208 and stored
in memory 210 for access by control circuit 206.
[0050] FIG. 4 is an example of a motion sensor signal 250 that may be acquired by motion
sensor 212 over a cardiac cycle. Vertical dashed lines 252 and 262 denote the timing
of two consecutive ventricular events (an intrinsic ventricular depolarization or
a ventricular pace), marking the respective beginning and end of the ventricular cycle
251. The motion signal includes an A1 event 254, an A2 event 256, an A3 event 258
and an A4 event 260. The A1 event 254 is an acceleration signal (in this example when
motion sensor 250 is implemented as an accelerometer) that occurs during ventricular
contraction and marks the approximate onset of ventricular mechanical systole. The
A1 event is also referred to herein as a "ventricular contraction event" The A2 event
265 is an acceleration signal that occurs during ventricular relaxation and marks
the approximate offset or end of ventricular mechanical systole. The A2 event is also
referred to herein as the "ventricular relaxation event." The A3 event 258 is an acceleration
signal that occurs during passive ventricular filling and marks ventricular mechanical
diastole. The A3 event is also referred to herein as the "ventricular passive filling
event." Since the A2 event occurs with the end of ventricular systole, it is an indicator
of the onset of ventricular diastole. The A3 event occurs during ventricular diastole.
As such. the A2 and A3 events may be collectively referred to as ventricular mechanical
diastolic events because they arc both indicators of the ventricular diastolic period.
[0051] The A4 event 260 is an acceleration signal that occurs during atrial contraction
and active ventricular filling and marks atrial mechanical systole. The A4 event 260
is also referred to herein as the "atrial systolic event" or merely the "atrial event,"
and is the atrial systolic event that is detected from motion sensor signal 250 by
atrial event detector circuit 240 for controlling pace timing circuit 242 to trigger
ventricular pacing pulse delivery by starting an AV pacing interval in response to
detecting the A4 event. 260. As described below, control circuit 206 may be configured
to detect one or more of the A1, A2, and A3 events from motion sensor signal 250,
for at least some ventricular cardiac cycles, for use in positively detecting the
A4 event 260 and setting atrial event detection control parameters. The A1, A2 and/or
A3 events may be detected and characterized to avoid false detection of A4 events
and promote reliable A4 event detection for proper timing of atrial-synchronized ventricular
pacing pulses.
[0052] FIG. 5 is a flow chart 300 of one method performed by pacemaker 14 for detecting
the A4 event and controlling ventricular pacing. At block 302, control circuit 206
identifies a ventricular event. The ventricular event may be an R-wave sensed event
signal received from sensing circuit 204 or a ventricular pacing pulse delivered by
pulse generator 202. Since the ventricular A1, A2 and A3 events may have different
characteristics during an intrinsic ventricular rhythm than during a ventricular paced
rhythm, the methods described herein for determining amplitudes, time intervals or
other characteristics of the A1, A2 and A3 events for use in setting A4 detection
control parameters or confirming A4 event detection may be determined for both an
intrinsic ventricular rhythm and a ventricular paced rhythm.
[0053] For example, as described in conjunction with the flow charts and timing diagrams
presented herein, various time intervals, sensing windows, atrial refractory period,
and atrial event detection threshold amplitude may be set based on characterizations
of one or more of the A1, A2 and A3 events. One set of A4 detection control parameters
and characteristics of the A1, A2 and A3 events may be determined and stored for use
during episodes of ventricular sensing (ventricular intrinsic rhythm), and another
set of A4 detection control parameters and characteristics of the A1, A2 and A3 events
may be determined and stored for used during episodes of ventricular pacing.
[0054] During ventricular sensing, control circuit 206 may be configured to discriminate
a normal sinus R-wave from a premature ventricular contraction (PVC) so that ventricular
events identified at block 302 for use in starting a search for the A1 through A4
events from the motion sensor signal do not include PVCs. When a ventricular event,
sensed or paced, is identified at block 302 that is not a PVC, pace timing circuit
242 may set an escape interval timer to a lower rate (LR) pacing interval. If the
lower rate pacing interval expires (as described below in conjunction with block 315),
a ventricular pacing pulse may be delivered, asynchronous to atrial activity, in order
to maintain some minimum, base ventricular rate.
[0055] At block 304, atrial event detector 240 detects the A1 through A3 motion signals.
Briefly, atrial event detector 240 may compare the motion sensor signal to one or
more pre-determined detection threshold amplitudes during one or more time windows
set in response to identifying the ventricular event at bock 302 for detecting the
A1 through A3 events. In some examples, the A4 event may also be detected at block
304 to increase confidence in the positive identification of each of the four motion
sensor signals A1 through A4 in a given cardiac cycle. In this example, the A1 through
A3 events, and optionally A4, may be detected on a beat-by-beat basis.
[0056] After the A1 through A3 events are detected, the A1 -A3 time interval is determined
at block 304 as the time interval from the A1 event detection to the A3 event detection.
The A1-A3 time interval may be used to update an A1-A3 interval trend at block 308.
For example, a running average A1-A3 time interval may be updated at block 308 using
the most recent N A1-A3 time interval measurements, e.g., the most recent three to
twelve A1-A3 time intervals.
[0057] The A1-A3 time interval is used to set a post-ventricular atrial refractory period
at block 310. This atrial refractory period is also referred to herein as an "A4 refractory
period" because A4 event detection is inhibited during the atrial refractory period.
When a ventricular event is identified at block 302, atrial event detector 240 may
start the atrial refractory period at block 310. The atrial refractory period may
be set to a percentage longer than or a fixed interval longer than the A1-A3 time
interval. For example, the atrial refractory period may be set to be 50 to 150 ms
longer than the A1-A3 time interval, though shorter or longer fixed intervals may
be added to the A1-A3 time interval for setting the atrial refractory period. The
fixed time interval used to set the atrial refractory period may vary depending on
heart rate in some examples.
[0058] During the atrial refractory period, any motion sensor events that are detected,
or cross a detection threshold amplitude, are ignored for the purposes of triggering
a ventricular pacing pulse and starting an AV pacing interval. Ventricular mechanical
events A1 through A3 may be detected during the atrial refractory period, as indicated
at block 304, to determine the A1-A3 time interval and update the A1-A3 interval trend
(blocks 306 and 308), either periodically or on a beat-by-beat basis.
[0059] At block 312, atrial event detector circuit 240 monitors the motion sensor signal
to detect the A4 event after the expiration of the atrial refractory period. If the
A4 event is not detected before the lower pacing rate interval expires (block 315),
a ventricular pacing pulse is delivered at block 316 to ensure a minimum ventricular
rate, e.g.. 40 to 60 beats per minute. Furthermore, it is to be understood that if
an intrinsic R-wave is sensed before an A4 event is detected, the process of FIG.
5 may return to block 302 where the sensed R-wave is identified as a ventricular electrical
event and control circuit 206 restarts the process of detecting the A4 event on the
next ventricular cycle.
[0060] If the A4 event is detected before the lower pacing rate interval expires, control
circuit 206 sets the AV pacing interval at block 314 in response to detecting the
A4 event. If an intrinsic R-wave is not sensed from the cardiac electrical signal
by sensing circuit 204 during the AV pacing interval, "no" branch of block 316, a
ventricular pacing pulse is delivered by pulse generator 202 at block 318 upon expiration
of the AV pacing interval. The ventricular pacing pulse, if delivered, and otherwise
the sensed R-wave, is identified as the next ventricular event at block 302 and the
process repeats.
[0061] In this way, the A1 through A3 events may be detected from the motion sensor signal
on a beat-by-beat (or less frequent) basis for updating the A1-A3 time interval trend
used to set the atrial refractory period to provide a high likelihood of positively
detecting the A4 event and properly timing a ventricular pacing pulse in synchrony
with the atrial event. Other motion sensor signal events A1 through A3 are unlikely
to be falsely detected as the A4 event. by applying the atrial refractory period set
based on the A1-A3 timing.
[0062] In some examples, rather than determining an A1-A3 time interval, a time interval
to the A2 event may be determined so that the atrial refractory period is set based
on the A1-A2 time interval to extend through at least the A2 event. and expire before
the A3 event. In this example, an A4 detection threshold amplitude may be set higher
than an expected A3 event amplitude to allow detection of the A4 event earlier in
the ventricular cycle, for example as the atrial rate is increasing. In other cases,
the time interval from the identified ventricular electrical event to the A1, A2 or
A3 event may be determined and used in setting the atrial refractory period.
[0063] In some examples, the process of blocks 304 through 308 is performed periodically
rather than on a beat-by-beat basis. For example detection of A1-A3 events during
the atrial refractory period may occur on every third cardiac cycle, every eighth
cardiac cycle, once a minute or other predetermined schedule for updating the A1-A3
time interval (or other ventricular event time interval as discussed above) used for
setting the atrial refractory period at block 310. In some cases, the heart rate,
paced or intrinsic, may be monitored and the A1-A3 events may be detected for updating
the A1-A3 interval trend when the heart rate changes by more than a predetermined
amount. For example, ventricular event intervals between consecutive ventricular events
may be determined upon identifying ventricular events at block 302. The ventricular
event. intervals may be RR intervals between consecutively sensed intrinsic R-waves
or VV intervals between consecutively delivered ventricular pacing pulses and may
include RV intervals between a sensed intrinsic R-wave and a consecutively delivered
pacing pulse and VR intervals between a delivered pacing pulse and a consecutively
sensed R-wave. Both the intrinsic heart rate and the paced rate may change, e.g.,
when pacemaker 14 is a rate responsive pacemaker. If the ventricular event interval
changes or a trend in the ventricular event interval changes by more than a predetermined
amount, the control circuit may perform blocks 304 through 308 to update the A1-A3
interval trend used for setting the atrial refractory period.
[0064] In other examples, if the A4 event is not detected at block 312 after the atrial
refractory period and before the next ventricular event (intrinsic or paced) is identified
at block 302, the control circuit 206 may perform the process of blocks 304 through
306 for a predetermined number of consecutive or non-consccutivc cardiac cycles to
update the A1-A3 interval trend used to set the atrial refractory period to restore
A4 detection.
[0065] FIG. 6 is an example of a motion sensor signals 400 and 410 acquired over two different
cardiac cycles. A ventricular pacing pulse is delivered at time 0.0 seconds for both
cardiac cycles. The top sensor signal 400 is received over one cardiac cycle and the
bottom sensor signal 401 is received over a different cardiac cycle. The two signals
400 and 410 are aligned in time at 0.0 seconds, the time of the ventricular pacing
pulse delivery.
[0066] The A1 events 402 and 412 of the respective motion sensor signals 400 and 410, which
occur during ventricular contraction, are observed to be well-aligned in time following
the ventricular pacing pulse at time 0.0 seconds. Similarly, the A2 events 404 and
414 (occurring during ventricular relaxation) and the A3 events 406 and 416 (occurring
during passive ventricular filling) are well-aligned in time. Since the A1, A2 and
A3 events are ventricular events, occurring during ventricular contraction, ventricular
relaxation, and passive ventricular filling, respectively, these events are expected
to occur at relatively consistent intervals following a ventricular electrical event,
the ventricular pacing pulse in this example, and relative to each other. The time
relationship of the A1, A2 and A3 events may be different following a ventricular
pacing pulse compared to following a sensed intrinsic R-wave, however, during a stable
paced or intrinsic ventricular rhythm, the relative timing of A1, A2 and A3 events
to each other and the immediately preceding ventricular electrical event is expected
to be consistent.
[0067] The A4 events 408 and 418 of the first and second motion sensor signals 400 and 410
respectively are not aligned in time. The A4 event occurs during atrial systole and
as such the time interval of the A4 event following the immediately preceding ventricular
electrical event (sensed R-wave or ventricular pacing pulse) and the preceding A1
through A3 events may vary between cardiac cycles.
[0068] The consistency of the timing of the A1 through A3 events relative to each other
and the immediately preceding ventricular electrical event. may be used for determining
the atrial refractory period and increasing confidence in reliably detecting A4 events
408 and 418. In some examples, an A1 sensing window 420 may be set based on an expected
Vpace-A1 time interval. The Vpace-A1 time interval 430 may be measured when the motion
sensor signal 400 or 410 crosses an A1 sensing threshold amplitude 440. The A1 sensing
window 420 may be adjusted on the next cardiac cycle based on the Vpace-A1 time interval
430 determined on the current cardiac cycle or a running average Vpace-A1 time interval.
[0069] An A2 sensing window 422 may be set based on an expected Vpace-A2 time interval (not
explicitly shown but understood to be the total time from 0.0 seconds to an A2 event
detection) or an A1-A2 time interval 432 (time from A1 detection to time of A2 detection).
The A2 event 404 or 414 may be detected at the time of the first positive-going crossing
of an A2 sensing threshold amplitude 442 by the motion sensor signal 400 or 410 during
the A2 sensing window 422. The A2 sensing window 422 may be adjusted on the next cardiac
cycle based on the Vpace-A2 time interval or A1-A2 time interval 432 determined on
the current cardiac cycle.
[0070] Similarly, an A3 sensing window 424 may be set based on an expected Vpace-A3 time
interval (not explicidy labeled but understood to be sum of time intervals 430 and
434), A1-A3 time interval 434, or A2-A3 time interval (not explicitly labeled but
understood to be the time interval from the sensed A2 event 404 or 414 to the sensed
A3 event 406 or 416). The A3 event 406 or 416 may be detected during the A3 sensing
window 424 when the motion sensor signal 400 or 410, respectively, crosses an A3 sensing
threshold amplitude 444. The A3 sensing window 424 may be adjusted on the next cardiac
cycle based on the Vpace-A3 time interval, A1-A3 time interval 434, or the A2-A3 time
interval determined during the current cardiac cycle.
[0071] Each of the sensing windows 420, 422 and 424 may be set based on a history of time
intervals determined from a ventricular pacing pulse or sensed intrinsic R-wave to
the respective A1 event 402 or 412, A2 event 404 or 414 and A3 event 406 or 416 or
based on a history of time intervals between the detected A1, A2 and A3 events or
any combination thereof. For example, the A2 sensing window 422 may be set to start
based on time intervals measured between a ventricular pacing pulse or sensed R-wave
and the detected A1 event. The end of the A2 sensing window 422 may be set to start
based on an A1-A2 time interval 432 or based on an A1-A3 time interval 434. It is
recognized that numerous methods may be conceived for setting the A1, A2 and A3 sensing
windows 420, 422 and 424, respectively, based on the consistency of the expected time
intervals between any combinations of the ventricular electrical event. (paced or
sensed) and subsequent A1, A2 and A3 events. Furthermore, it is contemplated that
these sensing windows 420, 422 and 424 may be set according to different control parameters,
such as different fixed time intervals added to or subtracted from measured event
time intervals depending on whether the ventricular electrical event is a paced or
sensed event and/or depending on heart rate The event time intervals that may be measured
and used for setting the onset, offset and duration of the sensing windows 420, 422
and 424 may include any of the Vpace-A1, Vpace-A2, Vpace-A3, Rsense-A1, Rsense-A2,
Rsense-A3, A1-A2, A1-A3, and/or A2-A3 time intervals determined during a paced and/or
intrinsic rhythm.
[0072] The sensing threshold amplitudes 440, 442 and 444 may be set uniquely during each
of the respective sensing windows 420, 422 and 424, respectively, or set to a fixed
value for all sensing windows. The sensing threshold amplitudes 440, 442, and 444
may be fixed or decaying thresholds and may be automatically adjusted thresholds set
to starting threshold values based on the peak motion sensor signal amplitude detected
during each respective window 420, 422 and 424. The motion sensor signals 400 and
410 are shown as raw signals, but the motion sensor signal may be filtered, amplified
and rectified by circuitry included in motion sensor 212 to provide control circuit
206 with a rectified signal that is used to detect the A1 through A4 events.
[0073] A post-ventricular, atrial refractory period 436 may be set based on the A1-A3 time
interval 434 or based on the Vpace-A3 time interval (sum of Vpace-A1 interval 430
and A1-A3 time interval 434). In some examples, the atrial refractory period 436 ends
upon the expiration of the A3 sensing window 424. In other examples, the atrial refractory
period 436 ends after the expiration of the A3 sensing window 424. The A4 event 408
or 418 may be detected in response to the first positive-going crossing of an A4 sensing
threshold amplitude 446 by the rectified motion sensor signal.
[0074] In some examples, the A4 detection is confirmed when the A1, A2 and A3 events have
each been detected during the atrial refractory period 436. If any one of the A1,
A2 or A3 events was not detected during the atrial refractory period 436, the A4 event
detection based on a crossing of threshold 446 may not be confirmed and not used for
starting an AV pacing interval. In other examples, at least one of the A1, A2 or A3
events may be required to be detected during a respective sensing window 420, 422,
or 424 on a beat-by-beat basis for confirming an A4 detection after the atrial refractory
period 436.
[0075] The A1, A2 and/or A3 events sensed during the respective A1 sensing window 420, A2
sensing window 422 and A3 sensing window 424 may be used for updating the atrial refractory
period 436 as described in conjunction with FIG. 5 on a beat-by-beat or less frequent
basis without requiring positive detection of each of A1, A2, and/or A3 for confirming
an A4 detection on each beat. Setting the atrial refractory period based on detection
and relative timing of the A1 through A3 events enables the atrial refractory period
to be set based on the consistent timing of the ventricular motion sensor signal events
so that A4 events may be detected with high reliability even when the timing of the
A4 event relative to the A1-A3 events and the preceding ventricular electrical event
is variable.
[0076] FIG. 7 is an averaged motion sensor signal 500 that may be determined by control
circuit 206 by averaging the motion sensor signal obtained over multiple cardiac cycles,
e.g., signals 400 and 410 of FIG. 6. The averaged motion sensor signal 500 may represent
the average of 3 to 20 or other predetermined number of cardiac cycles. The raw motion
sensor signal or a filtered, amplified and/or rectified motion sensor signal may be
buffered beginning from a ventricular electrical event, pacing pulse or sensed R-wave,
at time 0.0 seconds until the next ventricular electrical event. The buffered motion
sensor signal obtained over one cardiac cycle may be averaged with the buffered motion
sensor signals obtained over a predetermined number of other cardiac cycles to produce
averaged motion sensor signal 500.
[0077] A ventricular electrical signal 510 is shown aligned in time with averaged motion
sensor signal 500. Ventricular electrical signal 510 may be passed from sensing circuit
204 to control module 206 and includes an R-wave 512, which may be an evoked or intrinsic
R-wave, and a T-wave 514. R-wave 512 is followed by the ventricular contraction A1
event 502. The ventricular relaxation A2 event 504 occurs during T-wave 514. The passive
ventricular filling A3 event 506 occurs after T-wave 514.
[0078] Since the A1, A2 and A3 events are ventricular mechanical events, they occur at consistent
time intervals relative to each other and relative to ventricular electrical events
(R-wave 512 and T-wave 514). As a result, the signal-to-noise ratio of the A1 signal
502, A2 signal 504 and A3 signal 506 is improved in the averaged motion sensor signal
500 compared to the single-cycle motion sensor signals 400 and 410 of FIG. 6. The
averaged Al event 502, A2 event 504 and A3 event 506 have an improved signal-to-noise
ratio compared to the A1, A2 and A3 events observed in the motion sensor signal 400
or 410 of a single cardiac cycle as shown in FIG. 6, making A1, A2, and A3 event detection
from the averaged motion signal 500 more reliable.
[0079] A single event. detection threshold amplitude 540 may be defined such that the first
positive-going crossing of the threshold 540 by the averaged, rectified motion sensor
signal 500 within the A1 sensing window 520, A2 sensing window 522 and A3 sensing
window 524 is detected as the respective A1 event 502, A2 event 504, and A3 event
506. Alternatively, unique detection threshold amplitudes may be defined for each
sensing window 520, 522 and 524 for detecting the respective A1, A2 and A3 events.
The sensing windows 520, 522 and 524 may be initially set according to expected A1,
A2 and A3 event timing following the ventricular pacing pulse or R-wave 512 and may
be adjusted according to the actual detection time of each respective A1 event. 502,
A2 event 504. and A3 event 506. The sensing windows 520, 522 and 524 may be set based
on ventricular pacing rate or atrial event rate, e.g., based on A4-A4 event intervals.
The sensing windows 520, 522 and 524 may also be set differently following a ventricular
pacing pulse than following an intrinsic R-wave sensed event since the timing of the
A1, A2 and A3 events and T-wave 514 may be altered during ventricular pacing compared
to during an intrinsic ventricular rhythm.
[0080] The atrial systolic A4 event timing, which is independent of the ventricular electrical
event timing, may be more variable from one cardiac cycle to the next with respect
to the ventricular electrical and mechanical events, e.g., as shown by the relative
timing of the A4 events 408 and 418 of signals 400 and 410 (FIG. 6). As a result,
the A4 signal is largely attenuated in the averaged motion signal 500 in FIG. 7. The
improved signal-to-noise ratio of the A1 through A3 events and attenuation of the
A4 event in the averaged motion signal 500 enables control circuit 206 to reliably
detect the signal averaged A1 event 502, A2 event 504 and A3 event 506 for determining
one or more ventricular event time intervals for use in setting A1, A2 and A3 detection
windows 420, 422, and 424, respectively, setting detection threshold amplitudes for
detecting the A1, A2, A3 and/or A4 events, and/or setting atrial refractory period
436 used on a beat-by-beat basis for A4 event detection as shown in FIG. 6.
[0081] For example, a ventricular R-wave or pacing pulse to A1 time interval 530, an A1-A3
time interval 534, A1-A2 time interval 536, a ventricular R-wave or pacing pulse to
A3 time interval 516, and/or a T-wave to A3 time interval 518 may be determined by
control circuit 206 from the averaged motion signal 500 and the cardiac electrical
signal 510. The atrial refractory period 436 is started upon delivering a ventricular
pacing pulse or sensing an intrinsic R-wave. The atrial refractory period 436 may
be set to expire after a predetermined time interval, e.g., 30 to 100 ms, after the
A3 time interval 516. For instance, if time interval 516 is 700 ms, the atrial refractory
period 436 may be set to expire 750 ms after the ventricular pacing pulse or sensed
R-wave that started the atrial refractory period. Instead of using a time interval
ending with the A3 event detection, a time interval ending with the A2 event detection
may be determined and used in controlling the duration of the atrial refractory period
436. As described above, the A2 event, which occurs during T-wave 514, is an indicator
of the end of ventricular mechanical systole and the onset of ventricular mechanical
diastole, The A3 event occurs during ventricular mechanical diastole, during the passive
ventricular filling phase. As such the timing of the A2 event 504 or the timing of
the A3 event 506 relative to another ventricular electrical event (ventricular pacing
pulse, R-wave 512, or T-wave 514) may be used for controlling the duration and expiration
time of atrial refractory period 436. In other words, the timing of a ventricular
mechanical diastolic event, A2 event 504 or A3 event 506, may be determined and used
to set the atrial refractory period 436 that is applied on a beat-by-beat basis for
detecting A4 events.
[0082] The T-wave 514 may be sensed by sensing circuit 206 on a beat-by-beat basis by control
circuit 206 or by sensing circuit 204 from cardiac electrical signal 510. The T-wave
514 may be sensed at a maximum peak amplitude of a rectified cardiac electrical signal
or a maximum absolute peak amplitude in a non-rectified cardiac signal received by
control circuit 206 from sensing circuit 204. Alternatively, T-wave 514 may be sensed
by sensing circuit 204 in response to the cardiac electrical signal crossing a T-wave
sensing threshold amplitude after the ventricular pacing pulse or R-wave sensed event
signal. In some cases, a T-wave sensing window may be applied after the R-wave sensed
event signal or a delivered pacing pulse to facilitate T-wave sensing.
[0083] The T-wave 514 may be sensed during the atrial refractory period 436. Control circuit
206 may terminate the atrial refractory period 436 at a predetermined time interval
after sensing T-wave 514. For instance if the T-wave to A3 time interval 518 is determined
to be 150 ms from the averaged motion signal 500, control circuit 206 may terminate
the atrial refractory period 436 at 180 ms after sensing the T-wavc to promote reliable
sensing of the A4 event.
[0084] Atrial event detector circuit 240 may be a processor-based circuit that determines
the averaged motion sensor signal 500 over multiple cardiac cycles, detects A1, A2
and A3 events 502, 504, and 506 from the averaged motion sensor signal 500, and sets
the atrial refractory period 436 based on the timing of at least one ventricular mechanical
diastolic event, e.g., the A3 event 506, detected from the average motion sensor signal
500. In other examples, the A2 event is used as a ventricular diastolic mechanical
event for marking the approximate timing of the onset of ventricular diastole. The
A4 event, e.g., event 408 or 418 (FIG. 6) may be detected on a beat-by-beat basis
from the non-averaged motion sensor signal after the atrial refractory period 436
expires.
[0085] FIG. 8 is a flow chart 600 of a method performed by pacemaker 14 for detecting atrial
events and controlling atrial-synchronized ventricular pacing according to another
example. At block 602, a ventricular electrical event is identified, which may be
a sensed intrinsic R-wave or delivered ventricular pacing pulse. A lower rate pacing
interval may be set at block 602 upon identifying the ventricular electrical event,
as described in conjunction with FIG. 5, in order to maintain a minimum, base ventricular
rate in the absence of A4 event detections.
[0086] At block 604, the motion sensor signal is buffered over the cardiac cycle, e.g.,
until the next ventricular electrical event is identified. At block 606, the buffered
motion signal is averaged with buffered motion sensor signals acquired over a predetermined
number of cardiac cycles to obtain an averaged motion signal with improved A1, A2
and A3 signal-to-noise ratio and attenuated A4 signal compared to the non-averaged
motion sensor signal.
[0087] At block 608 the A1-A3 time interval or a ventricular electrical event to A3 time
interval is determined from the averaged motion sensor signal by detecting the signal
averaged A1, A2 and A3 events as described above in conjunction with FIG. 7. The A3
time interval is used to set the atrial refractory period at block 610 by atrial event
detector circuit 240. As described above, the atrial refractory period may be set
a predetermined percentage or fixed time interval longer than the A1-A3 time interval
or a ventricular electrical event to A3 Lime interval or set to expire upon expiration
of an A3 sensing window that is defined based on relative timing of the A1, A2, and
A3 events, In other examples, an A2 time interval is determined at block 608 for use
in setting the A4 refractory period. The A2 and A3 events are ventricular mechanical
diastolic event markers that may be used for controlling the timing of the expiration
of the A4 refractory period to occur near the start or during the ventricular passive
filling phase, before the active ventricular filling phase associated with atrial
systole.
[0088] The atrial refractory period is started at block 610 upon identifying a ventricular
electrical event (pacing pulse or R-wave sensed event) at block 602. In some examples,
signal averaging and determination of the A3 time interval (or A2 time interval) for
setting the atrial refractory period may occur on a beat-by-beat basis using an averaged
motion signal. In other examples, the A3 time interval is determined periodically
or in response to a change in the atrial rate, e.g., determined from A4-A4 intervals,
or a change between a sensed and paced ventricular rhythm. The most recently updated
A3 time interval (or A2 time interval) determined from the averaged motion sensor
signal may be used to set the atrial refractory period at block 610. The expiration
of the atrial refractory period may be set on the fly during an already started atrial
refractory period based on the A3 time interval determined during the current ventricular
cycle. In other examples, the A3 time interval determined on a preceding ventricular
cycle is used to set the atrial refractory period for the current ventricular cycle
so that the atrial refractory period ends during or after an expected time of the
A3 event, or in some cases prior to an expected A3 event but after an expected A2
event.
[0089] In other examples, the duration of the atrial refractory period may be controlled
on a beat-by-beat basis by starting the atrial refractory period upon the identified
ventricular event, sensing the T-wave during the atrial refractory period, and terminating
the atrial refractory period a predetermined time interval after the sensed T-wave,
where the predetermined time interval is based on the T-wave to A3 time interval 518
determined from the averaged motion signal 500 (FIG. 7).
[0090] If an A4 event is detected from the non-averaged motion sensor signal at block 612,
after the atrial refractory period expires, an AV pacing interval is set at block
614. The A4 event may be detected based on an A4 detection threshold amplitude crossing
by the raw motion sensor signal or by the rectified signal. The pace timing circuit
242 sets an AV pacing interval at block 614 in response to the detected A4 signal.
If an intrinsic R-wave is not sensed before expiration of the AV pacing interval,
as determined at block 616, the scheduled ventricular pacing pulse is delivered at
block 620. In some cases, the A4 event may not be detected before a lower rate pacing
interval expires at block 615. An atrial-asynchronous ventricular pacing pulse may
be delivered at block 620 if the lower rate pacing interval expires before an A4 event
is detected to maintain a programmed minimum ventricular base rate, causing the process
to return to block 602 where the ventricular pacing pulse is identified as the next
ventricular electrical event.
[0091] FIG. 9 is a flow chart 800 of a method for detecting A4 events for controlling atrial-synchronized
ventricular pacing. At block 802, a ventricular electrical event (ventricular pacing
pulse or sensed intrinsic R-wave) is identified. An atrial refractory period is set
at block 804. During the A4 refractory period, detection of an atrial systolic event,
the A4 event, from the motion sensor is with held or disabled. In this example, the
A4 refractory period is set based on the timing of the A1, A2 and/or A3 events such
that the A4 refractory period expires before the expected A3 event instead of after
it as described in conjunction with FIG. 8. As heart rate increases, the time interval
between the A3 and A4 events may shorten, and in some instances the A3 and A4 event.
signals become fused and appear as a single peak or become indistinguishable in the
motion sensor signal. When fusion of the A3 and A4 event signals occurs, a single
relatively larger amplitude signal may occur rather than the two relatively lower
amplitude A3 and A4 event signals temporally separated at distinctly different times
following the ventricular electrical event as shown in FIG. 4.
[0092] As such, the A4 refractory period in the process of flow chart 800 is set at block
804 to allow sensing of the A4 event at some point after tile expected A2 event but
not necessarily later than the expected A3 event. A higher A4 detection threshold
amplitude, however, may be used during an expected time interval of the A3 event.
The A4 detection threshold amplitude may be set to a starting threshold at block 806
that is greater than the A4 detection threshold amplitude that is used after an expected
time of the A3 event such that only a high amplitude motion sensor signal representing
the fused A3 and A4 events can be detected during an expected time interval of the
A3 event. The A4 detection threshold amplitude starts at an initially high level at
block 806 upon expiration of the relatively shorter A4 refractory period, and a threshold
adjustment interval is set at block 808.
[0093] The threshold adjustment interval may be a decay time or a drop time interval used
to time the adjustment of the A4 detection threshold amplitude to a second lower level
after the expected time of the A3 event. The A4 detection threshold amplitude may
decay from the starting high level over a predetermined decay interval or make a stepwise
drop from the starting high level to a second lower level after a predetermined drop
time interval has expired. The threshold adjustment interval may be set based on the
expected timing of the A3 event. An A3 time interval may be determined as described
previously herein, and the adjustment interval may be set at block 808 to expire a
predetermined time interval later than the A3 time interval. In other examples, the
threshold adjustment interval may correspond to an A3 window, e.g., window 524 of
FIG. 7, determined from the averaged motion sensor signal and may be a time interval
during which the A3 event is expected to occur.
[0094] If the motion sensor signal crosses the A4 detection threshold at block 810, the
control circuit 206 sets an AV pacing interval at block 818. If the threshold adjustment
interval expires before the A4 event is detected, "yes" branch of block 812, the A4
detection threshold is adjusted at block 814. The A4 detection threshold may be adjusted
by changing from a decaying threshold to a fixed threshold amplitude that is lower
than the starting threshold amplitude set at block 806. The A4 detection threshold
may alternatively be adjusted by dropping from the starting threshold to a second,
lower threshold amplitude in a step change. The A4 detection threshold may remain
at the fixed lower threshold amplitude until an A4 event is detected (or a lower pacing
rate interval expires) or may decay at the same or a different decay rate to a predetermined
minimum A4 detection threshold amplitude. In other examples, the A4 detection threshold
may decay at a fixed rate from the starting threshold set at block 806 until an A4
event is detected without setting or using a threshold adjustment interval. In each
of these examples, the A4 detection threshold remains at a generally higher amplitude
during the expected time of the A3 event and falls to a lower amplitude after the
expected time of the A3 event.
[0095] The control circuit 206 sets the AV pacing interval at block 818 in response to detecting
the A4 event at block 816. If an R-wave is sensed at block 820 during the AV pacing
interval, it is identified as the next ventricular electrical event at block 802 and
the process is repeated. If an intrinsic R-wave is not sensed during the AV pacing
interval, the scheduled ventricular pacing pulse is delivered by pacemaker 14 at block
822 upon expiration of the AV pacing interval. The pacing pulse is identified as the
next ventricular electrical event at block 802, and the process is repeated for detecting
the next A4 event during the next ventricular cycle.
[0096] While not shown explicitly in FIG. 9, it is contemplated that a back-up pacing interval
or lower rate pacing interval may be set upon identifying the ventricular electrical
event at block 802. If the A4 event is not detected before expiration of the back-up
or lower rate pacing interval, a ventricular pacing pulse may be delivered that is
not tracked to a detected A4 event. The use of a lower rate pacing interval set upon
identifying the ventricular electrical event for maintaining a minimum ventricular
rate in the absence of a detected A4 event is described above in conjunction with
FIG. 5 (blocks 302 and 315) and FIG. 8 (blocks 602 and 615), and the use of the lower
rate pacing interval may be combined with the process of FIG. 9. Furthermore, it is
to be understood that if an intrinsic R-wave is sensed before an A4 event is detected,
the process of FIG. 9 may return to block 802 to detect the A4 event on the next ventricular
cycle.
[0097] FIG. 10 is a timing diagram 850 of a motion sensor signal 854 that may be received
by pacemaker 14. Distinct A3 events 856 and A4 events 858 are observed following ventricular
pacing pulses 851 during the first three ventricular cycles. If the paced or intrinsic
atrial rate increases, fusion of the A3 and A4 events may occur producing high amplitude
motion sensor signals representing the fused A3/A4 events 880 as observed on the next
three ventricular cycles.
[0098] The control circuit 206 sets an A4 refractory period 860 that expires before an A3
interval 862, which may be determined as the time interval from a ventricular electrical
event to the A3 event identified from an averaged motion sensor signal as described
above in conjunction with FIG. 7 and FIG. 8. The A4 refractory period 860 may extend
from a delivered ventricular pacing pulse 851 (or sensed intrinsic R-wave) through
the A1 and A2 events and expire before an expected time of the A3 event but after
an expected time of the A2 event. In some examples, the atrial refractory period 860
is set to extend longer than an A2 time interval determined from the averaged motion
sensor signal or throughout and expiring with a previously determined A2 window.
[0099] Upon expiration of the A4 refractory period 860, the A4 detection threshold 870 is
set to a starting amplitude 872. In this example, the starting threshold amplitude
872 is held constant for a threshold adjustment interval 876 then drops step-wise
to a second, lower threshold amplitude 874. The threshold adjustment interval 876
may be equal to an A3 window representing the expected time window of the A3 event.
The motion sensor signal 854 crosses the second, lower threshold amplitude 874 during
the first three ventricular cycles, resulting in A4 event detections of the non-fused
A4 events 858 of the motion sensor signal. An AV pacing interval 878 may be set in
response to detecting each of the A4 events 858 for timing delivering of the next
ventricular pacing pulse 851. The AV pacing interval may be set to 100 ms or less,
for example to 50 ms, to provide desired synchrony between the atrial systolic A4
event and the subsequent electrical depolarization of the ventricle.
[0100] The fused A3/A4 events 880 are detected when the motion sensor signal 854 crosses
the first higher A4 detection threshold amplitude 872. The control circuit 206 may
set an AV pacing interval based on the fused A3/A4 event detections. In some examples,
the AV pacing interval 878 may be modified when the motion sensor signal crosses the
higher threshold amplitude 872 during the threshold adjustment interval 876 compared
to when the A4 event is detected based on a crossing of the second lower threshold
amplitude 874. The AV pacing interval 878 may be adjusted in order to promote separation
of the A3 and A4 events. For example, the AV pacing interval 878 may be shortened
so that the A3 event occurs earlier in the subsequent ventricular pacing cycle to
separate the A3 event from the A4 event.
[0101] In FIG. 10, the A4 refractory period 860 extends through an expected A2 event time
but expires before an expected A3 event time. The A4 detection threshold 870 set upon
expiration of the A4 refractory period starts at a high level 872 and drops to a second,
lower level 874 after the threshold adjustment interval 876 that extends after the
expected A3 event time. In other examples, the A4 refractory period 860 may be shorter,
for example extending through the expected time of the A1 event, but expiring before
the expected time of the A2 event. In still other examples, the A4 refractory period
860 is set to zero (or not set at all). In each of these instances, the A4 detection
threshold 870 is set to an initially high level that is decreased, e.g., at a predetermined
decay rate, slope or in one or more stepwise drops, to a second lower detection threshold
amplitude at some point after the expected time of the A3 event such that only a high
amplitude signal representative of a fused A3/A4 event signal can be detected during
the time from the ventricular electrical event through an expected time of the A3
event.
[0102] The first higher level threshold amplitude 872 and the second lower level threshold
amplitude 874 may be predetermined values or set based on peak amplitudes determined
from the motion sensor signal. For example, the starting higher level threshold amplitude
872 may be set based on a peak amplitude of the A1 event. A3 event, A4 event, or fused
A3/A4 event. For instance, when a fused A3/A4 event is detected, during the threshold
adjustment interval 876, the peak amplitude of the fused A3/A4 event may be determined.
The starting, higher level threshold amplitude 872 may be set to a percentage of the
peak amplitude of the fused A3/A4 event on the next ventricular cycle.
[0103] In another example, the peak A1, A2 and/or A3 amplitudes are determined from the
motion sensor signal 854 for an individual cardiac cycle or an averaged motion sensor
signal determined by aligning and averaging multiple ventricular cycles, e.g., averaged
signal 500 of FIG. 7. The starting, higher threshold amplitude 872 may be set based
on the A1, A2 and/or A3 amplitudes so that the A4 detection threshold 870 remains
above an expected A3 peak amplitude through the expected time of the A3 event.
[0104] FIG. 11 is a flow chart 801 of a method for controlling atrial synchronized ventricular
pacing by pacemaker 14 according to another example. Blocks 802, 804, 806, 808 and
810 in FIG. 11 correspond to identically-numbered blocks described above in conjunction
with FIG. 9. In the process shown in FIG. 11, if the A4 event is detected during the
threshold adjustment interval at block 810, in response to a higher threshold amplitude
crossing, the detected A4 event is likely a fused A3/A4 event as described in conjunction
with FIG. 10. At block 815, control circuit 206 may set the AV pacing interval to
an adjusted interval in response to detecting the fused A3/A4 event during the threshold
adjustment interval. The adjusted AV pacing interval may be shortened from the target
AV pacing interval set when the A4 event is detected after the threshold adjustment
interval and is separated from the A3 event in time. For example, if the target AV
pacing interval is 250 to 300 ms, the adjusted AV pacing interval may be shortened
by up to 100 ms to separate the A3 and A4 events. When the ventricular pacing pulse
is delivered earlier after the A4 event, at a shorter AV pacing interval, the A3 event
occurs earlier in the subsequent ventricular cycle since it is a ventricular event
(representing passive ventricular filling) and therefore follows the earlier timing
of the ventricular pacing pulse.
[0105] If the A4 event is detected at block 816 in response to a motion sensor signal crossing
of the adjusted lower threshold amplitude (block 814), after the threshold adjustment
interval expires (bock 812), the AV pacing interval is set at block 818 to the target
AV interval. The target AV interval may be determined to optimize atrioventricular
synchrony at relatively lower heart rates or when clear temporal separation of the
atrial and ventricular motion sensor signals is present. Blocks 812, 814, 816, 818,
820 and 822 correspond to identically-numbered blocks described above in conjunction
with FIG. 9.
[0106] FIG. 12 is a flow chart 900 of another example of a method for controlling atrial-synchronized
ventricular pacing by pacemaker 14. A ventricular electrical event is identified at
block 902. In response to identifying the ventricular electrical event, the control
circuit 206 sets the A4 refractory period at block 903 to a "long" A4 refractory period
that expires after the expected time of the A3 event so that the A4 event is only
detected after an expected time of the A3 event following the identified ventricular
event.
[0107] During the A4 refractory period, the motion sensor signal may be monitored for identifying
the A3 event signal and determining it peak amplitude at block 904. If the A3 and
A4 events become fused, a large amplitude signal may occur during the long A4 refractory
period, e.g., during an A3 window 424 set during the A4 refractory period as shown
in FIG. 6. A maximum absolute peak amplitude of the motion sensor signal during the
long A4 refractory period and its timing during the A4 refractory period, or a maximum
amplitude specifically during the A3 window, may be determined for detecting fusion
of the A3 and A4 events when the A4 event is not detected outside the A4 refractory
period as further described below.
[0108] After expiration of the A4 refractory period, the A4 detection threshold is set at
block 905 to a relatively low threshold amplitude, e.g., corresponding to the second,
lower level threshold amplitude 874 shown in FIG. 10. The low threshold amplitude
may be greater than the expected amplitude of the A3 events but less than the expected
amplitude of the A4 events. Control circuit 206 waits for the motion sensor signal
to cross the A4 detection threshold at block 906. If a ventricular electrical event
occurs before an A4 event is detected, as determined at block 908, control circuit
206 may determine a peak amplitude of the motion sensor signal at block 910. If a
large peak amplitude signal occurred during the expected A3 event time, within the
A4 refractory period or within an A3 window, fusion of the A3 and A4 events may be
detected. A large peak amplitude signal may be detected when the motion sensor signal
crosses a predetermined fusion detection threshold prior to expiration of the A4 refractory
period. The fusion detection threshold may be set to a higher threshold amplitude,
e.g., threshold amplitude 872 shown in FIG. 10, which is greater than the A4 detection
threshold amplitude set at block 906 after expiration of the long A4 refractory period.
Control circuit 206 may be configured to detect fusion by determining a peak amplitude
of the motion sensor and comparing the peak amplitude to a fusion detection threshold
when the motion sensor signal amplitude does not cross the A4 detection threshold
amplitude after the A4 refractory period.
[0109] In some examples, the motion sensor signal is buffered in memory 210 during the long
A4 refractory period, or only during an A3 window, to enable detection of a large
amplitude signal at block 910 only if an A4 event is not detected at block 906 before
the next ventricular electrical event. The ventricular electrical event may be a sensed
intrinsic R-wave or a back-up ventricular pacing pulse delivered if a back-up or lower
rate pacing interval has expired without detecting an A4 event or sensing an intrinsic
R-wave.
[0110] If a large amplitude signal during the A4 refractory period is not detected at block
910, indicating unlikely fusion of the A3 and A4 events, control circuit 206 may adjust
A4 detection parameters at block 912. For example, the A4 detection threshold may
be reduced and/or the A4 refractory period may be shortened. In some examples, control
circuit 206 may repeat an analysis of the averaged motion sensor signal 500 as shown
in FIG. 7 to re-determine expected timing and amplitude of the A1, A2 and/or A3 events.
The relative timing of the ventricular mechanical events to the each other and/or
the preceding ventricular electrical event and their respective amplitudes may be
used for adjusting the A4 refractory period and/or A4 detection threshold amplitude
to promote A4 event detection.
[0111] If a large amplitude signal is detected at block 910, fusion of the A3 and A4 events
is indicated. At block 916, control circuit 206 enables fused A3/A4 event detection.
For example, fused A3/A4 event detection may be enabled by adjusting the A4 refractory
period to a relatively shorter interval, such as the A4 refractory period 860 of FIG.
10 that expires before the expected A3 event time. Fused A3/A4 event detection may
be enabled by allowing A4 events to be detected during the long A4 refractory period
if the motion sensor signal crosses a high A4 detection threshold amplitude during
the A4 refractory period. In some examples, fused A3/A4 event detection is enabled
by setting the A4 detection parameters according to the techniques shown and described
in conjunction with FIG. 10 which use a short A4 refractory period 860 and a variable
A4 detection threshold 870 controlled using a threshold adjustment interval 876. Any
of the other techniques described above in conjunction with FIG. 10 for detecting
a fused A3/A4 event signal during an expected A3 event time may be enabled at block
916.
[0112] Pacemaker 14 operates using the enabled fused A3/A4 detection control parameters
for detecting A4 events and setting the AV pacing interval for delivering atrial synchronized
ventricular pacing pulses. While the fused A3/A4 detection control parameters are
enabled, however, control circuit 206 may monitor detected A4 events to detect an
indication of non-fused A4 events . The A3 and A4 event signals may separate due to
a change in heart rate. Control circuit 206 may monitor for separation of the A4 event
signal from the A3 event signal at block 918 while the fused A3/A4 event detection
control parameters arc enabled, so that pacemaker 14 can switch back to the long A4
refractory period and lower A4 detection threshold amplitude for detecting A4 events
when the A3 and A4 events arc no longer fused.
[0113] An indication of a non-fused A4 event may be detected at block 918 in response to
an A4 event being detected later than the expected A3 event time, after a threshold
adjustment interval, and/or in response to the motion sensor signal crossing a relatively
low A4 detection threshold amplitude for one or more ventricular cycles. For instance,
using the example techniques of FIG. 10, if an A4 detection is made after the threshold
adjustment interval 876, which is later than an expected A3 event time and based on
the lower detection threshold amplitude 874, control circuit 206 detects an indication
of a non-fused A4 event at block 918. In some examples, control circuit 206 may detect
an indication of non-fused A4 events when A4 events are detected after the threshold
adjustment interval 876 consistently for a predetermined number of ventricular cycles,
e.g., at least 3 consecutive ventricular cycles.
[0114] If an indication of non-fused A4 events is detected at block 918, control circuit
206 may disable fused A3/A4 detection at block 920 by switching back to setting the
"long" A4 refractory period that expires after an expected A3 event time and setting
the A4 detection threshold amplitude back to a relatively low threshold amplitude
beginning from the expiration of the A4 refractory period. The process returns to
block 902 to identify the next ventricular electrical event and detect A4 events according
to the detection control parameters set at blocks 903 and 905.
[0115] When the A4 events are detected outside the A4 refractory period, "yes" branch of
block 906, control circuit 206 may be configured to monitor the motion sensor signal
for detecting an indication of A3-A4 interval shortening at block 914. If A3 events
are being detected during an A3 window (during the long A4 refractory period), the
A3-A4 time interval may be determined directly at block 914. One or more A3-A4 time
intervals may be required to be less than a threshold time interval or successively
decreasing by a threshold amount e.g., compared to a preceding A3-A4 time interval,
for detecting the indication of A3-A4 interval shortening at block 914.
[0116] In other examples, indirect metrics that indicate that the A3-A4 interval may be
shortening may be determined at block 914. For example, A4-A4 intervals may be determined
and if the A4-A4 intervals are decreasing, indicating an increase in atrial rate,
an indication of A3-A4 interval shortening may be detected at block 914. In another
example, at time interval from the ventricular electrical event or the A1 event to
the A2 or A3 event may be determined at block 914. If the time interval between the
ventricular electrical event or the A1 ventricular systolic mechanical event to the
subsequent A2 or A3 ventricular diastolic mechanical events is shortening, this may
be an indication of A3-A4 interval shortening.
[0117] If an indication of A3-A4 interval shortening is not detected, "no" branch of block
914, control circuit 206 continues to detect A4 events based on the detection control
parameters set at blocks 903 and 905. If an indication of shortening is detected at
block 914, the fused A3/A4 detection control parameters may be enabled at block 916
in anticipation that the A3 and A4 events may become fused on subsequent ventricular
cycles. In some examples, when an indication of A3-A4 interval shortening is detected
at block 914, the AV pacing interval may be adjusted at block 915, e.g., shortened
from the AV pacing interval set when A3-A4 interval shortening is not being detected,
to increase separation of the A3 and A4 events in addition to or alternatively to
enabling the fused A3/A4 detection control parameters at block 916. If the A3-A4 time
interval is determined to increase or lengthen again, or an indirect indicator of
a lengthening of the A3-A4 time interval is determined, an indication of non-fused
A4 events may be detected at block 918. The control circuit may disable the fused
A3/A4 detection control parameters at block 920.
[0118] While not shown explicitly in FIG. 12, it is to be understood that throughout the
operation of control circuit 206 for detecting A4 events using the detection control
parameters set at blocks 903 and 905 or using fused A3/A4 detection control parameters
enabled at block 916, pace timing circuit 242 sets the AV pacing interval in response
to detected A4 events for controlling pulse generator 202 to deliver ventricular pacing
pulses in an atrial synchronized pacing mode. Adjustments to the AV pacing interval
may occur in response to detecting fused A3/A4 events or an indication of A3-A4 time
interval shortening or both to promote an increased separation of the A3 and A4 events.
Furthermore, it is understood that if A4-A4 event intervals become shorter than an
atrial tracking limit, indicating the atrial rate is faster than a desired maximum
tracking rate, pacemaker 14 may switch to a non-atrial tracking pacing mode. AV pacing
intervals are not set in response to A4 event detection in this situation. Pace timing
circuit 242 may set lower rate pacing intervals (VV pacing intervals) to maintain
a minimum ventricular rate by delivering ventricular pacing pulses upon expiration
of the lower rate pacing intervals, asynchronous to the atrial events.
[0119] FIG. 13 is a flow chart 950 of a method for controlling ventricular pacing by pacemaker
14 according to another example. At block 952, a ventricular electrical event is identified,
and the subsequent A3 and A4 events are detected at block 954 using any of the techniques
described above. The A3-A4 time interval is determined at block 956. If A3-A4 interval
shortening is not detected (block 958) based on a comparison to a previous A3-A4 time
interval or to a shortening threshold interval, pace timing circuit 242 sets the AV
pacing interval at block 960 to control pulse generator 202 to deliver the next ventricular
pacing pulse at a target AV pacing interval from the A4 event.
[0120] A decreasing trend of the A3-A4 time interval may be detected at block 958, for example
in response to shortening of the A3-A4 time interval compared to a preceding A3-A4
time interval or a predetermined number of consecutively decreasing A3-A4 time intervals.
If A3-A4 shortening is detected, the AV pacing interval is adjusted at block 962.
The AV pacing interval may be shortened by control circuit 206 to promote temporal
separation of the A3 and A4 events by controlling pulse generator 202 to deliver the
next ventricular pacing pulse at block 964 earlier after the A4 event than the target
AV pacing interval used at block 960. The earlier ventricular pacing pulse causes
the A3 event to occur earlier in the next ventricular cycle, ahead of the next A4
event.
[0121] At block 966, the A3-A4 time interval after the earlier ventricular pacing pulse
delivered at the shortened AV pacing interval is determined. The A3-A4 time interval
may be compared to a threshold time interval at block 968 to determine if acceptable
separation of the A3 and A4 events has occurred. If the A3-A4 time interval is acceptable
at block 968, the AV pacing interval may be maintained at the adjusted interval unless
further A3-A4 time interval shortening is detected at block 958. It is to be understood
that the AV pacing interval may be shortened in response to detecting a shortening
of the A3-A4 interval up to a predetermined maximum number of times or down to a minimum
allowed AV pacing interval.
[0122] In some examples, control circuit 206 may periodically increase the AV pacing interval
at block 970 when the A3-A4 interval is acceptable at block 968 to determine if the
AV pacing interval can be increased again while still maintaining separation of the
A3-A4 interval. If the A3-A4 interval is not less than an acceptable time interval
threshold at block 958, after increasing the AV pacing interval for one or more pacing
cycles, the AV pacing interval may be adjusted back to the target AV pacing interval
at block 960, Control circuit 206 may be configured to monitor the A3-A4 time interval
to maintain a maximum temporal separation of the A3 and A4 events by adjusting the
AV pacing interval to the longest AV pacing interval that maintains a maximum or optimally
increased A3-A4 time interval.
[0123] Various examples of an intracardiac pacemaker configured to deliver atrial-synchronized
ventricular pacing have been described according to illustrative embodiments. The
ventricular intracardiac pacemaker is configured to detect A4 events from a motion
sensor signal for controlling the atrial-synchronized ventricular pacing according
to various methods described above. The methods described herein and represented by
the accompanying flow charts and timing diagrams may combined or modified to include
steps performed in a different order or combination than the illustrative examples
shown. Furthermore, other circuitry may be conceived by one of ordinary skill in the
art for implementing the techniques disclosed herein; the particular examples described
herein are illustrative in nature and not intended to be limiting. It is appreciated
that various modifications to the referenced examples may be made without departing
from the scope of the disclosure and the following claims.
[0124] Further embodiments, which can be combined with other embodiments described herein,
are described in the following clauses. Any features described as part of one of these
clauses can be used on or in conjunction with other embodiments described herein to
yield yet a further embodiment. It is intended that the description also includes
such modifications, variations and combinations.
- 1. An intracardiac ventricular pacemaker, comprising:
a pulse generator configured to generate and deliver pacing pulses to a ventricle
of a patient's heart via electrodes coupled to the pacemaker;
a motion sensor configured to produce a motion signal comprising an atrial systolic
event and a ventricular diastolic event indicating a passive ventricular filling phase;
and
a control circuit coupled to the motion sensor and the pulse generator and configured
to:
set a detection threshold to a first amplitude during an expected time interval of
the ventricular diastolic event and to a second amplitude lower than the first amplitude
after the expected time interval of the ventricular diastolic event;
detect the atrial systolic event in response to the motion signal crossing the detection
threshold;
set an atrioventricular pacing interval in response to detecting the atrial systolic
event; and
control the pulse generator to deliver a pacing pulse to the ventricle in response
to the atrioventricular pacing interval expiring.
- 2. The pacemaker of clause 1, wherein the control circuit is configured to adjust
the detection threshold from the first amplitude to the second amplitude at a decay
rate over the expected time interval of the ventricular diastolic event.
- 3. The pacemaker of any of clauses 1-2, wherein the control circuit is further configured
to start an atrial refractory period upon a ventricular electrical event and end the
atrial refractory period prior to the expected time interval of ventricular diastolic
event, wherein detection of the atrial systolic event is disabled during the atrial
refractory period.
- 4. The pacemaker of any of clauses 1-3, wherein the control circuit is configured
to:
set the atrioventricular pacing interval to a first interval in response to detecting
the atrial systolic event after the expected time interval of the ventricular diastolic
event;
set the atrioventricular pacing interval to a second interval in response to detecting
the atrial systolic event during the expected time interval of the ventricular diastolic
event, the second interval shorter than the first interval; and
control the pulse generator to deliver the ventricular pacing pulse upon expiration
of the atrioventricular pacing interval.
- 5. The pacemaker of any of clauses 1-4, wherein the control circuit is further configured
to:
detect a fusion of the ventricular diastolic event and the atrial systolic event in
response to the motion signal crossing the detection threshold during the expected
time interval of the ventricular diastolic event; and
adjust the atrioventricular pacing interval in response to detecting the fusion.
- 6. The pacemaker of any of clauses 1-5, wherein the control circuit is further configured
to:
set a first atrial refractory period to expire after the expected time interval of
the ventricular diastolic event during a first ventricular cycle, wherein detection
of the atrial systolic event from the motion signal is withheld during the first atrial
refractory period;
set the detection threshold to the second amplitude after expiration of the first
atrial refractory period;
responsive to the motion signal not crossing the second amplitude of the detection
threshold, shorten the first atrial refractory period to a second atrial refractory
period set to expire before the ventricular diastolic event during a second ventricular
cycle; and
set the detection threshold to the first amplitude upon expiration of the shortened
refractory period.
- 7. The pacemaker of any of clauses 1-6, wherein the control circuit is further configured
to:
set an atrial refractory period expiring after the expected time interval of the ventricular
diastolic event during a first ventricular cycle, wherein detection of the atrial
systolic event is inhibited during the atrial refractory period;
detect an indication of shortening of a time interval from the ventricular diastolic
event of the motion signal to the atrial systolic event of the motion signal; and
enable detection of the atrial systolic event during the time interval of the expected
ventricular diastolic event during a second ventricular cycle in response to detecting
the indication of shortening.
- 8. The pacemaker of clause 7, wherein the control circuit is configured to enable
detection of the atrial systolic event by shortening the atrial refractory period
to expire before the expected time interval of the ventricular diastolic event and
enabling the detection threshold to be set to the first amplitude after expiration
of the shortened atrial refractory period.
- 9. The pacemaker of any of clauses 1-8, wherein the control circuit is configured
to:
detect an indication of shortening of a time interval from the ventricular diastolic
event of the motion signal to the atrial systolic event of the motion signal; and
adjust the atrioventricular pacing interval in response to detecting the indication
of shortening.
- 10. The pacemaker of any of clauses 1-9, wherein the control circuit is further configured
to:
set an atrial refractory period expiring after the expected time interval of the ventricular
diastolic event;
determine if the motion sensor signal exceeds a fusion detection threshold in response
to the motion signal not crossing the detection threshold after the atrial refractory
period;
detect fusion of the atrial systolic event and ventricular diastolic event in response
to the motion sensor signal exceeding the fusion detection threshold; and
enable detection of the atrial systolic event during the time interval of the expected
ventricular diastolic event in response to detecting the fusion.
- 11. The pacemaker of any of clauses 1-10, further comprising a housing enclosing the
pulse generator, the motion sensor, and the control circuit, wherein the electrodes
are housing-based electrodes.